An auxiliary medicinal product (AxMP) is a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product.
Examples of AxMPs are medicinal products used as background treatment, as rescue medication, as challenging agents, or to assess the endpoints. See also the Recommendations on auxiliary medicinal products in clinical trials. Furthermore, for a medicinal product to classify as AxMP, it should be related to and relevant for the design of the clinical trial, which excludes ‘concomitant medications’.
In principle, only authorised medicinal products may be used as AxMP in clinical trials (article 59 of the CTR). However, unauthorised auxiliary medicinal products may be used in certain circumstances, for instance if an authorised alternative AxMP is not available in the EU/EEA, or where the sponsor cannot reasonably be expected to use an authorised AxMP. This has to be justified in the protocol.
Where the AxMP is not authorised, or where an authorised AxMP is modified while such modification is not covered by a marketing authorisation, it shall be manufactured according to GMP requirements or to at least an equivalent standard, in order to ensure appropriate quality. The documentation requirements in the application dossier for IMPs also apply to unauthorised AxMPs.
Please note: unmodified authorised AxMPs only need to be listed in the cover letter, it is not necessary to enter these products in CTIS and submit an SmPC.